Catalog Number

CA-00000-000

Brand Name

N/A

Version/Model Number

CUVIS-spine

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201569

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

69480ca4-87c8-46c4-9da5-365f6b811e02

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-